Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-01-05
2026-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Interventions
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Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure
Eligibility Criteria
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Inclusion Criteria
2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study
Exclusion Criteria
2. Otorrhea or otitis media within 4 weeks prior to the operation
3. History of cholesteatoma
4. Perforations on the edge of the tympanic membrane
5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
6. Subject is taking systemic/oral corticosteroids
7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal
2 Years
100 Years
ALL
Yes
Sponsors
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Grace Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Michigan Ear Institute
Farmington Hills, Michigan, United States
Methodist Le Bonheur
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022.01
Identifier Type: -
Identifier Source: org_study_id
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